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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035874
Receipt No. R000040870
Scientific Title Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement
Date of disclosure of the study information 2019/02/28
Last modified on 2019/02/26

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Basic information
Public title Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement
Acronym Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement
Scientific Title Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement
Scientific Title:Acronym Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement
Region
Japan

Condition
Condition Alcohol use disorders
Classification by specialty
Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the effect of whether to contributes to reduction of impulsive drinking behavior by implementing cognitive behavioral therapy with attention bias correction training for patients with impaired alcohol use
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Symptoms of Addiction
(The Alcohol Use Disorders Identification Test)
Alcohol Relapse Risk Scale
Degree of inhibition of reaction to alcohol(stop-signal task)

Key secondary outcomes Environmental Reward Observation Scale
Acceptance and Action Questionnaire-II
Mindful Attention Awareness Scale
GHQ28
Attentional bias
(visual probe task)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 For the experimental group, we will perform a carefulness correction exercise in 6 sessions (about 20 minutes) out of all 8 programs.
Interventions/Control_2 For the control group, we will perform a carefulness correction exercise in 6 sessions (about 20 minutes) out of all 8 programs.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)
Oishi clinicPerson in hospital
(2)
Alcohol use disorders
(3)
At the time of the agreement acquisition; a person 20 years or older
(4)
The person that an agreement of study entry was provided from the person after a procedure of the informed consent
Key exclusion criteria (1)
The person who it was judged the chief physician to have difficulty in participation in this study
(2)
The person who feels extreme sleep
shortage or fatigue at the time of
study enforcement
(3)
The person who experiences
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironori SHIMADA
Organization Waseda University
Division name Faculty of Human Science
Zip code
Address 2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL +81-4-2949-8113
Email simac@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Midori TAKESAWA
Organization Waseda University
Division name Graduate School of Human Science
Zip code
Address 2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL +81-4-2949-8113
Homepage URL
Email m-takesawa@ruri.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人社団祐和会大石クリニック

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 14 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040870

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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